510(k) K014115 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
| Applicant | Portex, Inc., Keene NH, US |
| Decision | Substantially Equivalent, Feb 27, 2002 |
| Received | Dec 14, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8500P Terminated |
BTM | None listed |
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8503P Terminated |
BTM | None listed |
| May 22, 2003 | Sims Portex Inc. Portex 1st Response Adult Manual Resuscitators
Ref: 8506P Terminated |
BTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.